Courses and course dates
Compulsory courses (30 ECTS)
-
Discovery and Development of Medicines
-
Non-clinical Safety and Toxicology
-
Drug Regulatory Affairs in Drug Development
-
Drug Discovery
-
Drug Formulation and Delivery
-
Pharmacology
-
Clinical Pharmacology and Biostatistics
-
Process Development and Production of Active Pharmaceutical Ingredients (API)
-
QA QC GXP for Pharmaceutical Production
Elective courses (10-18 ECTS)
-
Pharmacoepidemiology and postauthorisation safety studies
-
Biotherapeutics Drug Development
-
Digital Health
-
Market Access for Pharmaceutical Products - Trends and Challenges
-
Pharmacovigilance: Signal detection and risk management
-
Big Data, Artificial Intelligence and Machine Learning in Drug Safety
-
Value Based Health Care - The Future for the Health Care Sector?
-
Independent elective study
Master's project (12-18 ECTS)
Courses from Master of Medicines Regulatory Affairs
-
Transparency and Trustworthiness in Drug Development
-
The US Regulatory Environment
-
The EU Regulatory Environment - Procedures and Applications
-
Quality - Drug Substance and Drug Product
-
Labelling as Driver for Regulatory Strategy
-
Clinical Development and Documentation
-
Drug Regulatory Science
-
Biopharmaceuticals - Quality Development and Documentation
-
Safety of Medicines - From Non-clinical Development to Pharmacovigilance
-
Global Pharmaceutical Policy - Rationales and Stakeholders